Hydrogel versus Bare Platinum Coils in Patients with Large or Recurrent Aneurysms Prone to Recurrence after Endovascular Treatment: A Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Some patients are at high risk of aneurysm recurrence after endovascular treatment: patients with large aneurysms (Patients Prone to Recurrence After Endovascular Treatment PRET-1) or with aneurysms that have previously recurred after coiling (PRET-2). We aimed to establish whether the use of hydrogel coils improved efficacy outcomes compared with bare platinum coils. MATERIALS AND METHODS: PRET was an investigator-led, pragmatic, multicenter, parallel, randomized (1:1) trial. Randomized allocation was performed separately for patients in PRET-1 and PRET-2, by using a Web-based platform ensuring concealed allocation. The primary outcome was a composite of a residual/recurrent aneurysm, adjudicated by a blinded core laboratory, or retreatment, intracranial bleeding, or mass effect during the 18-month follow-up. Secondary outcomes included adverse events, mortality, and morbidity (mRS > 2). The hypothesis was that hydrogel would decrease the primary outcome from 50% to 30% at 18 months, necessitating 125 patients per group (500 for PRET-1 and PRET-2). RESULTS: The trial was stopped once 250 patients in PRET-1 and 197 in PRET-2 had been recruited because of slow accrual. A poor primary outcome occurred in 44.4% (95% CI, 35.5%-53.2%) of those in PRET-1 allocated to platinum compared with 52.5% (95% CI, 43.4%-61.6%) of patients allocated to hydrogel (OR, 1.387; 95% CI, 0.838-2.295; P = .20) and in 49.0% (95% CI, 38.8%-59.1%) in PRET-2 allocated to platinum compared with 42.1% (95% CI, 32.0%-52.2%) allocated to hydrogel (OR, 0.959; 95% CI, 0.428-1.342; P = .34). Adverse events and morbidity were similar. There were 3.6% deaths (1.4% platinum, 5.9% hydrogel; P = .011). CONCLUSIONS: Coiling of large and recurrent aneurysms is safe but often poorly effective according to angiographic results. Hydrogel coiling was not shown to be better than platinum.

Patients prone to recurrence after endovascular treatment: periprocedural results of the PRET randomized trial on large and recurrent aneurysms.

BACKGROUND AND PURPOSE: Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial. MATERIALS AND METHODS: PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis. RESULTS: Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29% of PRET-1 and 4% of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50% of PRET-2 patients. They were wide-neck (≥4 mm) in 70% and in the posterior circulation in 24% of patients. Stents were used in 28% of patients (35% in PRET-2). Coiling was successful in 98%. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n=2, unrelated to treatment) and morbidity (defined as mRS>2 at 1 month) occurred in 25 patients (5.6%; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3% of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95% of patients were home with a good outcome (mRS≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4% of patients, with no significant difference between groups. CONCLUSIONS: Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils.

Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial.

BACKGROUND AND PURPOSE: The ability of polymer-modified coils to promote stable aneurysm occlusion after endovascular treatment is not well-documented. Angiographic aneurysm recurrence is widely used as a surrogate for treatment failure, but studies documenting the correlation of angiographic recurrence with clinical failure are limited. This trial compares the effectiveness of Matrix(2) polyglycolic/polylactic acid biopolymer-modified coils with bare metal coils and correlates the angiographic findings with clinical failure (ie, target aneurysm recurrence), a composite end point that includes any incident of posttreatment aneurysm rupture, retreatment, or unexplained death. MATERIALS AND METHODS: This was a multicenter randomized noninferiority trial with blinded end point adjudication. We enrolled 626 patients, divided between Matrix(2) and bare metal coil groups. The primary outcome was target aneurysm recurrence at 12 ± 3 months. RESULTS: At 455 days, at least 1 target aneurysm recurrence event had occurred in 14.6% of patients treated with bare metal coils and 13.3% of Matrix(2) (P = .76, log-rank test) patients; 92.8% of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment, and 5.8% of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage, with or without retreatment. Symptomatic re-intervention occurred in only 4 (0.6%) patients. At 455 days, 95.8% of patients with unruptured aneurysms and 90.4% of those with ruptured aneurysms were independent (mRS ≤ 2). Target aneurysm recurrence was associated with incomplete initial angiographic aneurysm obliteration, presentation with rupture, and a larger aneurysmal dome and neck size. CONCLUSIONS: Tested Matrix(2) coils were not inferior to bare metal coils. Endovascular coiling of intracranial aneurysms was safe, and the rate of technical success was high. Target aneurysm recurrence is a promising clinical outcome measure that correlates well with established angiographic measurements.

Endovascular mechanical thrombectomy for the treatment of acute ischemic stroke due to arterial dissection.

Arterial dissections account for 2% of strokes in all age groups, and up to 25% in patients aged 45 years or younger. The safety of endovascular intervention in this patient population is not well characterized. We identified all patients in the Merci registry - a prospective, multi-center post-market database enrolling patients treated with the Merci Retriever thrombectomy device - with arterial dissection as the most likely stroke etiology. Stroke presentation and procedural details were obtained prospectively; data regarding procedural complications, intracerebral hemorrhage (ICH), and the use of stenting of the dissected artery were obtained retrospectively. Of 980 patients in the registry, ten were identified with arterial dissection (8/10 ICA; 2/10 vertebrobasilar). The median age was 48 years with a baseline NIH stroke scale score of 16 and median time to treatment of 4.9 h. The procedure resulted in thrombolysis in cerebral ischemia (TICI) scores of 2a or better in eight out of ten and TICI 2b or better in six out of ten patients. Stenting of the dissection was performed in four of nine (44%). The single complication (1/9; 11%) - extension of a dissected carotid artery - was treated effectively with stenting. No symptomatic ICH or stroke in a previously unaffected territory occurred. A favorable functional outcome was observed in eight out of ten patients. Despite severe strokes on presentation, high rates of recanalization (8/10) and favorable functional outcomes (8/10) were observed. These results suggest that mechanical thrombectomy in patients with acute stroke resulting from arterial dissection is feasible, safe, and may be associated with favorable functional outcomes.

Drug eluting stents for symptomatic intracranial and vertebral artery stenosis.

The use of bare metal stents (BMS) to prevent recurrent stroke due to stenosis of the cerebral vasculature is associated with high rates of restenosis. Drug-eluting stents (DES) may decrease this risk. We evaluated the performance of DES in a cohort of patients treated at our institution.Consecutive patients treated with DES were identified by a case log and billing records; data regarding procedural details, clinical outcome and angiographic follow-up was obtained by retrospective chart review.Twenty-six patients (27 vessels; 14 vertebral origin (VO); 13 intracranial) were treated. Stenosis was reduced from mean 81% to 8% at the VO and 80% to 2% intracranially. No strokes occurred in the first 24 hours after stenting or at any time point in the VO group during a mean follow-up period of nine months. Among patients with intracranial stents, stroke with permanent disability occurred within 30 days in 1/12 (8%) and after 30 days in 1/11 (9%) with clinical follow-up (mean follow-up, 14 months). Follow-up catheter angiography was obtained in 14/14 (100%) in the VO group at mean eight months and in 8/11 surviving patients (73%) at a mean of ten months after stenting in the intracranial group. The restenosis rate was 21% at the VO (3/14) and 38% (3/8) for intracranial stents. Restenosis at the VO was less frequent than might have been expected from reports utilizing BMS, however, overall restenosis rates appeared higher than previously reported for patients with intracranial DES and comparable with restenosis rates for intracranial BMS.

Femoral artery complications associated with the Mynx closure device.

BACKGROUND AND PURPOSE: Devices to close a femoral arteriotomy are frequently used after catheterization for interventional radiology and cardiac procedures to decrease the time to hemostasis and ambulation and, potentially, to decrease local complications. The Mynx vascular closure device uses a sealant designed to occlude the access tract, resulting in hemostasis. MATERIALS AND METHODS: We retrospectively reviewed all cases in which the Mynx device was used and for which follow-up angiography was available. A total of 146 devices were deployed in 135 patients. A follow-up vascular study visualizing the femoral artery was performed in 26 patients (27 studies). RESULTS: There were 5 (5/27, 18%) cases of intravascular Mynx sealant on follow-up vascular imaging. Three pseudoaneurysms (3/27, 11%) were identified. CONCLUSIONS: In this small study, intravascular sealant and pseudoaneurysms were found frequently after femoral arterial closure with the Mynx vascular closure device.

Spontaneous brachial plexus hemorrhage-case report.

BACKGROUND: Shoulder hemorrhage resulting in brachial plexus neuropathy is a rare occurrence most often seen in cases of traumatic injury or anticoagulation therapy. We report a unique case of spontaneous brachial plexus hemorrhage. CASE DESCRIPTION: This is the first report of a spontaneous shoulder hemorrhage in which a 48-year-old jackhammer operator presented to the emergency department with a sudden onset of right shoulder pain and upper extremity pain and numbness. Imaging studies revealed a hematoma in the right axilla and chest wall. Without evidence of active bleeding or worsening neurologic deficit, this patient was treated conservatively with pain control and observation and eventually experienced a full recovery. Had there been persistent neurologic deficit, however, surgical evacuation would have been indicated. CONCLUSIONS: Cases of nerve compression caused by a hematoma should be analyzed on the basis of the severity of the neurologic deficit and not on the underlying cause of bleeding. Conservative treatment may be indicated in cases of mild or improving neurologic deficit, but regardless of its etiology, a hematoma that results in severe or worsening neurologic symptoms must be surgically evacuated to prevent permanent nerve damage.

Dural sinus thrombosis endovascular therapy.

Dural sinus thrombosis is a relatively rare, but potentially devastating disease. The problem occurs when there is extensive thrombosis of the intracranial dural sinuses, the outflow channels of venous blood from the brain. If recanalization does not occur, venous hypertension can lead to cerebral edema, infarction, and hemorrhage. Treatment of this disease usually involves anticoagulants, but with mixed results. Endovascular approaches using direct infusion of thrombolytic drugs into the occluded sinuses may result in excellent recanalization and improved patient outcomes.

Intra-arterial thrombolysis for acute stroke.

Intra-arterial thrombolysis is a developing modality for the treatment of the acute stroke that shows promise in restoring cerebral arterial supply. The rationale for treatment via the intra-arterial route rather than intravenously rests on increased recanalization with preliminary evidence suggesting improved outcome. Successful treatment is due in part to selecting patients who are not at increased risk for unwanted sequelae, namely intracranial hemorrhage, based on clinical and imaging features. The authors describe some points of technique for the procedure with an emphasis on interpretation of findings to guide therapy and solve problems.

Other endovascular treatment strategies for acute ischemic stroke.

This article discusses the efforts being made to develop a safe, efficacious method of clot removal in the treatment of acute ischemic stroke. Four endovascular treatment strategies are discussed: mechanical clot disruption, endovascular thrombectomy, stents, and therapeutic carotid occlusion.

Cavernous sinus sampling is highly accurate in distinguishing Cushing's disease from the ectopic adrenocorticotropin syndrome and in predicting intrapituitary tumor location.

Inferior petrosal sinus sampling (IPSS) is used to distinguish pituitary Cushing's disease from occult cases of the ectopic ACTH syndrome, but is limited in that it requires the use of ovine CRH (oCRH) and is not highly accurate at predicting the intrapituitary location of tumors. This study was designed to determine whether cavernous sinus sampling (CSS) is as safe and accurate as IPSS, whether CSS can eliminate the need for oCRH stimulation, and whether CSS can accurately predict the intrapituitary location of tumors. Ninety-three consecutive patients with ACTH-dependent Cushing's syndrome were prospectively studied with bilateral, simultaneous CSS before and after oCRH stimulation. Prediction of a pituitary or ectopic ACTH source was based on cavernous/peripheral plasma ACTH ratios. Intrapituitary tumor location was predicted based on lateralization (side to side) ACTH ratios. These predictions were compared to surgical outcome in the 70 patients who had surgically proven pituitary (n = 65) or ectopic (n = 5) disease. CSS distinguished pituitary Cushing's disease from the ectopic ACTH syndrome in 93% of patients with proven tumors before oCRH administration and in 100% of patients with proven tumors after oCRH. It was as safe and efficacious as published IPSS results. CSS accurately predicted the intrapituitary lateralization of the tumor in 83% of all patients and 89% of those patients with good catheter position and symmetric venous flow. CSS is as safe and accurate as IPSS for distinguishing patients with pituitary Cushing's disease from those with the ectopic ACTH syndrome. In addition, CSS appears to be superior to IPSS for predicting intrapituitary tumor lateralization.

Clinical and angiographic outcomes, with treatment data, for patients with cerebral aneurysms treated with Guglielmi detachable coils: a single-center experience.

OBJECTIVE: The purpose of this report is to provide the most detailed treatment and outcome data currently available in the literature, to allow for the further evaluation of Guglielmi detachable coils (GDC) as an appropriate treatment option for patients with cerebral aneurysms. METHODS: During a period of 4.5 years, 74 patients with intracerebral aneurysms were treated with GDC in the Department of Neurosurgery at Oregon Health Sciences University. A comprehensive retrospective and prospective analysis of these patients was performed, to assess the overall angiographic and clinical outcomes for these patients. RESULTS: Seventy-seven aneurysms were treated, with an average angiographic follow-up period of 1.4 years. Initially, 40% of aneurysms exhibited complete (100%) occlusion, 52% near complete (90-99%) occlusion, and 8% incomplete (<90%) occlusion. The average clinical follow-up period was 2.2 years. For unruptured aneurysms, 85% of patients returned to independent status. Of patients of Hunt and Hess Grade I/II status, 81% were independent; of patients of Grade III status, 100% were independent; and, of patients of Grade IV/V status, 50% were independent. The procedure-related morbidity rate was 9.1%, with a 7.8% risk of death from aneurysm perforation, stroke, or delayed hemorrhage. No completely occluded aneurysm hemorrhaged after GDC treatment (follow-up period, 1.9 yr). Of near complete occlusions, 2.6% hemorrhaged after embolization, at a rate of 1.4%/yr (follow-up period, 1.9 yr). CONCLUSION: This study details long-term clinical outcomes after GDC treatment and describes factors affecting the need for retreatment. Although complete anatomic cure was not obtained in all cases and the long-term protection from subarachnoid hemorrhage remains to be determined, these data indicate that GDC are a safe and efficacious treatment for cerebral aneurysms.

The use of electrolytically detachable coils in treating high-flow arteriovenous fistulas.

BACKGROUND AND PURPOSE: High-flow arteriovenous fistulas (AVFs) are commonly treated by using an endovascular approach with a variety of materials. The use of a Guglielmi electrolytically detachable coil (GDC) provides the ability to reposition or remove the coil if its position is not optimal and may minimize the risk of coil migration or distal embolization. This study reports our experience in using these coils alone or in combination with other materials in the treatment of intracranial and cervical high-flow fistulas. METHODS: Twelve patients with AVFs were treated with GDCs via the transvenous or transarterial-transfistulous routes. The six dural AVFs treated transvenously were also treated transarterially, and the GDCs were combined with fibered coils in three of these patients and in two other patients with pial AVFs. All patients have been clinically followed up for 12 to 48 months (mean, 28 months). RESULTS: Angiographic obliteration was obtained in all 12 patients. The fistulas have remained closed in 11 patients, as ascertained by angiographic confirmation in two patients and by clinical examination in nine patients. The one patient with recurrence experienced neurologic improvement and refused further treatment. GDCs required repositioning before detachment in seven patients, and no migration occurred after detachment. CONCLUSION: GDCs are useful for the treatment of high-flow AVFs. They afford more control in the placement of coils and may provide an anchoring point for more thrombogenic materials.

The role of angioplasty in the treatment of cerebrovascular disease.

Percutaneous transluminal angioplasty (PTA), an established treatment of arterial stenosis in coronary, renal, and other peripheral sites, is being applied to the cerebrovascular territory with greater frequency. Early results suggest that PTA may be safe and efficacious in the treatment of extracranial arterial stenosis secondary to atherosclerosis and fibromuscular dysplasia. PTA is also being used with promising results in treating symptomatic intracranial arterial stenosis from atherosclerosis. This review examines PTA in the treatment of cerebrovascular disease, current indications, and results.

Endovascular treatment of traumatic dural sinus thrombosis: case report.

OBJECTIVE: Dural sinus thrombosis has rarely been associated with closed head injury. We present a unique case involving the use of endovascular thrombolysis in the treatment of traumatic dural sinus thrombosis, which has not been reported. CLINICAL PRESENTATION: A 20-year-old male patient suffered a severe closed head injury while skiing. He developed refractory elevated intracranial pressure requiring barbiturate coma. Angiography demonstrated thrombosis of the dominant right transverse and sigmoid sinuses, with partial thrombosis of the superior sagittal sinus. Urokinase was administered via a microcatheter within the thrombus as a bolus of 250,000 units and then as a continuous infusion of 60,000 to 100,000 units per hour for 48 hours. The patient was maintained in a barbiturate coma and heparinized. Serial angiography was performed to assess the sinus patency and efficacy of thrombolysis. RESULTS: After 48 hours of thrombolysis, angiography demonstrated normal patency of the superior sagittal, right transverse, and right sigmoid sinuses. The intracranial pressure decreased after thrombolysis and was manageable with conventional techniques. Within 48 hours of the completed thrombolysis, the barbiturates were withdrawn and the patient's neurological status rapidly improved until the time of discharge 2 weeks later. DISCUSSION AND CONCLUSION: This case documents a rare instance of traumatic dural sinus thrombosis resulting from a closed head injury. In addition, endovascular thrombolysis resulted in subsequent opening of the dural sinuses and effective intracranial pressure management, despite the presence of a hemorrhagic contusion. Heparin was effective in maintaining sinus patency and was used safely in conjunction with urokinase in this setting of head injury.

Catastrophic subarachnoid hemorrhage resulting from ruptured vertebrobasilar dolichoectasia: case report.

OBJECTIVE AND IMPORTANCE: Two patients with vertebrobasilar dolichoectasia sustained massive fatal subarachnoid hemorrhage from rupture of the basilar artery wall. Hemorrhage from this entity is not widely known to occur during its natural history and may be exacerbated by systemic anticoagulation. CLINICAL PRESENTATION: Two patients presented with ischemic events of the brain stem, which were attributed to vertebrobasilar dolichoectasia. The diagnosis was made on the basis of computed tomography and subsequent angiography. INTERVENTION: Both patients were treated with systemic anticoagulation with heparin and subsequently experienced massive fatal subarachnoid hemorrhage. Autopsy results confirmed the cause of hemorrhage to be frank rupture of the basilar artery wall. CONCLUSION: Vertebrobasilar dolichoectasia is a formidable structural entity afflicting the posterior circulation, which is generally thought to cause symptoms as a result of either compression of the adjacent brain stem and/or cranial nerves or ischemic events caused by thrombosis and perforator occlusion. Our experience with these two patients indicates that some lesions can hemorrhage, which is a factor that must be weighed when considering treatment alternatives.

Current concepts on carotid artery-cavernous sinus fistulas.

With greater understanding of the pathophysiological mechanisms by which carotid artery-cavernous sinus fistulas occur, and with improved endovascular devices, more appropriate and definitive treatments are being performed. The authors define cartoid cavernous fistulas based on an accepted classification system and the signs and symptoms related to these fistulas are described. Angiographic evaluation of the risk the lesion may pose for precipitating stroke or visual loss in the patient is discussed. The literature on treatment alternatives for the different types of fistulas including transvenous, transarterial, and conservative management is reviewed.

Foreign bodies in small arteries after use of an infusion microcatheter.

Over a 31-month period, we performed four neurointerventional procedures after which unexpected foreign bodies were noted in multiple arteries. All four procedures had in common the use of Fastracker-18 infusion microcatheters. Histologically, the intravascular debris looked strikingly similar to the hydrophilic coating on the catheter. An in vitro test mimicking clinical use of the microcatheter revealed that the hydrophilic coating can separate from the catheter. Until the coating is refined to make it more resistant to stripping, it may be advisable to reduce the amount of back-and-forth movement of these microcatheters if they have been positioned through guide catheters with small inner diameters and angled tips.

Rotational vertebral artery occlusion: a mechanism of vertebrobasilar insufficiency.

OBJECTIVE: Symptomatic dynamic changes in blood flow secondary to vertebral artery compression with rotational head motion are evaluated in a series of patients as a cause for posterior circulation transient ischemic attacks. These cases are classic examples of rotational vertebral artery occlusion and allow for the discussion of the anatomic basis, angiographic features, and treatment options. ILLUSTRATIVE CASES: In our series, symptoms of vertebrobasilar insufficiency were reproducible with rotational head movement. Compression of the vertebral artery was demonstrated angiographically. The correct site of occlusion of the vertebral artery was apparent only by dynamic angiography with progressive head rotation. All of the patients presented in the illustrative cases had occlusion at the C2 level; however, one patient had been previously misdiagnosed and another had an additional site of occlusion. The anatomic course of the vertebral artery is described in addition to the sites of rotational occlusion. CONCLUSION: Rotational vertebral occlusion is an important cause of vertebrobasilar symptoms, which may lead to permanent neurological deficit if left undiagnosed. Dynamic angiography is the established method of diagnosis. Great care must be taken to avoid misdiagnosing the site of occlusion or missing a second occlusive site. For this reason, it is crucial to have a thorough understanding of the anatomic course of the vertebral artery and the muscular and tendinous insertions, which may cause rotational occlusion. The decision for treatment must be based on the site of occlusion as well as the assessment of the patient as a surgical candidate. A review of the literature reveals that surgical treatment is effective and must be considered to avoid further morbidity.

Intraoperative adrenocorticotropin levels during transsphenoidal surgery for Cushing's disease do not predict cure.

Recently, intraoperative rapid immunochemiluminometric assay (ICMA) ACTH measurements have been used to evaluate the completeness of resection of ectopic ACTH-secreting tumors. This study evaluates whether this method can be applied to patients undergoing transsphenoidal surgery (TSS) for Cushing's disease to predict complete pituitary tumor resection. Eighteen patients with Cushing's disease undergoing TSS had plasma ACTH concentrations measured by a standard ICMA every 10 min for 1 h immediately after pituitary tumor removal. Patients were evaluated postoperatively for cure by standard criteria. ACTH levels were evaluated for percentage decrease from baseline at each time point. Patients who were cured (n = 11) had statistically greater decreases in ACTH levels (mean decrease 54%) than patients who were not (n = 7; 26% mean decrease, P < 0.04). By Receiver-Operator Characteristic (ROC) analysis, a reduction of at least 40% best predicted which patients were cured and which were not cured. This level of reduction was observed in 82% of cured patients, and a reduction of less than 40% was observed in 71% of those not cured. The analysis misclassified 4 of the 18 patients, resulting in a diagnostic accuracy of 78%. Although the mean maximal decrease in ACTH concentrations after tumor removal was significantly different between cured and not cured patients with Cushing's disease, it was less dramatic than results in the previous ectopic ACTH study. This may relate to incomplete suppression and/or surgical manipulation of normal pituitary corticotrophs in patients with pituitary disease. In summary, in contrast to the ectopic ACTH syndrome, decline of plasma ACTH during TSS does not accurately predict complete tumor resection.